CDRH Monitors Chinese Titanium, Tells Devicemakers to Be Vigilant

CDRH is continuing to monitor titanium alloy imported from China and encouraging manufacturers to remain vigilant in their supplier controls.

After completing its initial assessment of defective titanium alloy imported from China, CDRH issued a letter to all affected devicemakers recommending they determine the impact of the material specification problem and take appropriate corrective actions, such as recalls, CDRH spokeswoman Peper Long said.

CDRH began investigating medical-grade titanium alloy imported from a Chinese mill last year. Although the titanium met industry standards, it had a defect known as alloy segregation, which means the metals weren’t melded homogenously.
The GMP Letter